Clinical trial comparing two medicines for the treatment of verruga Peruana
| ISRCTN | ISRCTN16597283 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16597283 |
| Secondary identifying numbers | G187OG-01 |
- Submission date
- 21/01/2016
- Registration date
- 11/03/2016
- Last edited
- 25/04/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Bartonellosis, also known as Carrión's disease, is an infectious disease caused by the bacteria Bartonella bacilliformis. It is very common in the Andes mountain range, particularly in Peru, and is spread through the bites of sand flies. The infection usually takes part in two distinct phases. The first stage is known as Oroya fever, which is potentially life-threatening as red blood cells are destroyed so the body is unable to carry enough oxygen around the body (haemolytic anaemia). The second stage is the verrucous stage (verruga peruana, also known as the Peruvian wart) and involves long-term (chronic) skin lesions (wounds) on the limbs and face. They can last for months or even years, and are often accompanied by fever, tiredness and muscle pain. The infection mainly affects children, as their immune systems are still developing and they have not had time to become resistant through long-term exposure to the disease. One the verrucous stage clears up, most people are free from infection, however some people are still infected and can pass on the disease, even if they don’t have any symptoms. Two common drugs used to treat people in the verrucous stage are azithromycin and rifampin, however it is not known whether one is more effective than the other. The aim of this study is to find out whether azithromycin or rifampin is faster at clearing up Bartonellosis in the verrucous stage.
Who can participate?
Anyone who is showing signs of a long term Bartonellosis in the verrucous stage.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are given rifampin treatment for two weeks, at a dose of 600mg tablets daily for participants over 8 years old and 10mg/kg daily of liquid medication for children under 8 years old. Those in the second group are treated with azithromycin a week for two weeks, at a dose of 1g for participants over 8 years old and 20mg/kg for children under 8 years old. Participants in both groups have blood samples taken at the start of the study and then again on day 7, 14, 40 and 60 in order to test the effectiveness of the medications. At these times, participants are also examined physically in order to see if their skin lesions have improved.
What are the possible benefits and risks of participating?
Participants could benefit from an improvement to their symptoms from the medications used in this study. There is a small risk of pain, bruising or infection from blood tests involved, as well as general side-effects associated with the medications used.
Where is the study run from?
Caraz Regional Hospital (Peru)
When is the study starting and how long is it expected to run for?
June 2003 to March 2004
Who is funding the study?
1. Uniformed Services University of the Health Sciences (USA)
2. Pfizer (USA)
Who is the main contact?
Dr David Blazes
david.blazes@usuhs.edu
Contact information
Scientific
Dept of Tropical Public Health
Uniformed Services University of the Health Sciences
4301 Jones Bridge Road
Bethesda
20814
United States of America
| Phone | +1 202 957 4446 |
|---|---|
| david.blazes@usuhs.edu |
Study information
| Study design | Community-based randomised parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | No specific participant information sheet available, please use the contact details below to request a further information. |
| Scientific title | A randomized controlled treatment trial for the verrucous stage of Bartonella bacilliformis infection in Peru |
| Study objectives | Thaim of this study is to determine the more efficacious drug for the treatment of the verrucous stage of Bartonella bacilliformis infection via a randomized, controlled trial, comparing azithromycin with rifampin. Null Hypotheses: 1. There is no difference between azithromycin and rifampin treatment in the time to resolution of the verrucous rash of Bartonella bacilliformis infection 2. There is no difference between azithromycin and rifampin treatment in the duration of Bartonella bacilliformis bacteremia associated with the verrucous rash |
| Ethics approval(s) | 1. Naval Medical Research Center, 28/06/2001, ref: FWA-00000152 2. Services University of the Health Sciences, 12/04/2001, ref: FWA-00001628 3. Peruvian University Cayetano Heredia, 04/09/2001, ref: FWA-00000525 |
| Health condition(s) or problem(s) studied | Bartonella bacilliformis infection |
| Intervention | Participants are randomly allocated to one of two groups using random computer generation of a scheme, blocked in groups of ten to ensure similar numbers will be assigned to each group. Group 1: Adult participants receive Rifamin for two weeks at a dose of 600mg PO daily, Ch receild participants receive 10mg/kg daily (not to exceeding 600mg PO daily). Group 2: Azithromycin .s administered once weekly for two weeks (which gives effective tissue levels for two weeks). Adults receive a 1.0 gram PO dose at Day 0 and Day 8 and children receive a 20mg/kg PO dose at Day 0 and Day 8 (not to exceed standard adult doses as above). For both groups, liquid elixirs are provided for children less than eight years of age, with tablets for all patients older than eight years. Participants in both groups are followed up after 7, 14, 30 and 60 days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | 1. Rifampin 2. Azithromycin |
| Primary outcome measure | 1. Time to resolution of verrucous lesions is measured from photographs and physical examinations undertaken at baseline, 7, 14, 30 and 60 days 2. Time to resolution of Bartonella bacteremia is measured through blood culture and PCR undertaken at baseline, 7, 14, 30 and 60 days |
| Secondary outcome measures | 1. Risk factors for Bartonella bacteremia measured using a questionnaire at baseline 2. Characteristics for clinical and laboratory findings associated with rash and Bartonella bacteremia measured at baseline, 7, 14, 30 and 60 days |
| Overall study start date | 16/06/2003 |
| Completion date | 30/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 127 |
| Key inclusion criteria | 1. Aged between 1 and 60 years 2. Clinical presentation compatible with Verruga peruana (chronic verrucous stage of Bartonellosis) 3. Able to provide informed consent/parental informed consent for children |
| Key exclusion criteria | 1. Pregnancy 2. Use of oral contraceptives 3. Breast-feeding 4. Admission to the hospital for an unrelated condition 5. Use of antibiotics within the month preceding potential enrollment in the trial 6. Chronic use of alcohol 7. Known chronic liver disease 8. Use of medications that potentially interact with rifampin or azithromycin during the study period |
| Date of first enrolment | 16/06/2003 |
| Date of final enrolment | 15/12/2003 |
Locations
Countries of recruitment
- Peru
Study participating centre
Caraz
Huaylas
Ancash
-
Peru
Sponsor information
University/education
4301 Jones Bridge Road
Bethesda
20814
United States of America
| Phone | +1 301 295 3734 |
|---|---|
| james.mancuso@usuhs.edu | |
"ROR" |
https://ror.org/04r3kq386 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Uniformed Services University, USU of the Health Science, Uniformed Services University of Health Sciences, The Uniformed Services University of the Health Sciences, USUHS, USU
- Location
- United States of America
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Pfizer Inc., Pfizer Consumer Healthcare, Davis, Charles Pfizer & Company, Warner-Lambert, King Pharmaceuticals, Wyeth Pharmaceuticals, Seagen
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/06/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of results papers in peer reviewed journals. The clinical trial data has also been presented at the ASTMH meeting in Philadelphia in November 2015. |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | Whole-Genome Analysis of Bartonella ancashensis, | 01/03/2017 | 25/04/2023 | Yes | No |
Editorial Notes
25/04/2023: Publication reference added.
